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SBRT in Early Breast Cancer in Elderly Women

RecruitingNAAges 75 Years - anyFemaleUniversity of Rome Tor Vergata
NCT05071105 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Surgical treatment represents the standard of local therapy in patients with early breast cancer, however in women over75, the comorbidities related to aging reduce the possibility of candidates for surgical treatment. In the United Kingdom it is estimated that over 40% of elderly women do not receive surgery for their breast cancer, and that their primary treatment is hormonal only, the so-called primary endocrinotherapy. In Italy the recent AIOM guidelines of 2019 exclude, in patients with hormone-sensitive disease and age older than 70, the omission of surgery in favor of hormone therapy alone, thus underlining the importance of a treatment local. However, there are currently no local treatments that could in any way effectively control the primary tumor. In recent years, SRT has widely found space as a therapeutic alternative in patients not fit for surgery. Stereotactic Radiother

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥ 75 years * Histologically confirmed diagnosis of local disease only (cT1-T2 N0 M0) * Luminal like A or B (estrogen receptor positive and/or progesterone receptor positive and Her2 negative Tumors) * SBRT within 2 months after hormonal therapy start Exclusion Criteria: * Metastatic Disease * Evidence of loco-regional nodal disease * Multifocal or multicentric tumors * Prior radiotherapy to the region of the study cancer that would result in overlap of therapy fields * Concurrent systemic disorders that contraindicate radiotherapy
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What it tests

  • Stereotactic Body Radiation Therapy
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Where

1 site
Fondazione Policlinico Tor Vergata
Rome, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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